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This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)
This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD)
The primary endpoint will be assessed as an average of Weeks 40, 44, and 48; additional secondary endpoints for efficacy will be assessed by visit over time
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSI-301 (Treatment Group A) | Experimental | Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44. |
|
| Aflibercept (Treatment Group B) | Active Comparator | Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KSI-301 | Drug | Intravitreal Injection |
| |
| Aflibercept |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48. | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. | Day 1 to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. | Day 1 to Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Velazquez-Martin, MD | Kodiak Sciences Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Research Institute, LLC | Phoenix | Arizona | 85014 | United States | ||
| Northwest Arkansas Retina Associates |
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Of 815 participants screened, 557 were randomized to treatment.
Participants were recruited based on physician referral at 94 medical centers between June 2021 and April 2022. The first participant was enrolled on 23 June 2021 and the last on 07 April 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | KSI-301 (Treatment Group A) | Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44. KSI-301: Intravitreal Injection |
| FG001 | Aflibercept (Treatment Group B) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2022 | Apr 4, 2024 |
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Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept.
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For masking purposes, sham injections will be administered at every monthly visit if an active treatment is not administered. To preserve masking, two investigators are required for this study. The masked Investigator will be responsible for the examinations and safety assessments. The unmasked Investigator will perform the injections and post-treatment assessments.
| Drug |
Intravitreal Injection |
|
|
| Sham Procedure | Other | The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. |
|
| Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Categorical improvements in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart | Day 1 to Week 48 |
| Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Categorical worsening in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart | Day 1 to Week 48 |
| Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. | Day 1 to Week 48 |
| Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. | Day 1 to Week 48 |
| Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) as assessed by a central reading center. | Day 1 to Week 48 |
| Springdale |
| Arkansas |
| 72762 |
| United States |
| California Retina Consultants | Bakersfield | California | 93309 | United States |
| Eye Medical Center of Fresno | Fresno | California | 93720 | United States |
| Retina Consultants of Orange County | Fullerton | California | 92835 | United States |
| UCSD Jacobs Retina Center | La Jolla | California | 92037 | United States |
| Retina Associates of Orange County | Laguna Hills | California | 92653 | United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| Retina Consultants of San Diego | Poway | California | 92064 | United States |
| Retina Consultants of Southern California | Redlands | California | 92374 | United States |
| Retinal Consultants Medical Group Inc | Sacramento | California | 95819 | United States |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | United States |
| Colorado Retina Associates PC | Lakewood | Colorado | 80228 | United States |
| Retina Group of New England | Waterford | Connecticut | 06385 | United States |
| Florida Eye Microsurgical Institute | Boynton Beach | Florida | 33426 | United States |
| Rand Eye Institute | Deerfield Beach | Florida | 33064 | United States |
| Retina Health Center | Fort Myers | Florida | 33907 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33703 | United States |
| Retina Associates of Florida | Tampa | Florida | 33609 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Springfield Clinic LLP | Springfield | Illinois | 62703 | United States |
| Talley Eye | Evansville | Indiana | 47710 | United States |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| Retina Associates PA | Lenexa | Kansas | 66215 | United States |
| Retina Associates of Kentucky | Lexington | Kentucky | 40509 | United States |
| Retina Group of Washington | Chevy Chase | Maryland | 20815 | United States |
| Cumberland Valley Retina Consultants PC | Hagerstown | Maryland | 21740 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| New England Retina Consultants | Springfield | Massachusetts | 01103 | United States |
| Vitreo Retinal Associates PC | Worcester | Massachusetts | 01603 | United States |
| Foundation for Vision Research | Grand Rapids | Michigan | 49525 | United States |
| Associated Retinal Consultants PC | Royal Oak | Michigan | 78073 | United States |
| Vitreoretinal Surgery PA | Edina | Minnesota | 55435 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| The Retina Center of New Jersey | Bloomfield | New Jersey | 07017 | United States |
| NJ Retina | Teaneck | New Jersey | 07605 | United States |
| Retina-Vitreous Surgeons of Central NY | Liverpool | New York | 13088 | United States |
| Retina Associates of Western NY | Rochester | New York | 14620 | United States |
| Western Carolina Retinal Associate PA | Asheville | North Carolina | 28803 | United States |
| Retina Associates of Cleveland | Cleveland | Ohio | 44130 | United States |
| Cleveland Clinic Foundation, Cole Eye Institute | Cleveland | Ohio | 44195 | United States |
| Retina Northwest | Portland | Oregon | 97210 | United States |
| Retina Consultants, LLC | Salem | Oregon | 97302 | United States |
| Cascade Medical Research Institute | Springfield | Oregon | 97477 | United States |
| MidAtlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| Retina Research of Beaufort | Beaufort | South Carolina | 29902 | United States |
| Charleston Neuroscience Institute | Ladson | South Carolina | 29456 | United States |
| Palmetto Retina Center | West Columbia | South Carolina | 296169 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Southeastern Retina Associates PC | Knoxville | Tennessee | 37909 | United States |
| Tennessee Retina PC | Nashville | Tennessee | 37203 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Consultants of Texas | Houston | Texas | 77030 | United States |
| Retina Consultants of Texas-(Katy) | Katy | Texas | 77494 | United States |
| Texas Retina Associates | Plano | Texas | 75075 | United States |
| Austin Retina Associates (Round Rock) | Round Rock | Texas | 78681 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas - (Woodlands) | The Woodlands | Texas | 77384 | United States |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | United States |
| Spokane Eye | Spokane | Washington | 99204 | United States |
| Emanuelli Research & Development Center LLC | Arecibo | 00612 | Puerto Rico |
Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered.
Aflibercept: Intravitreal Injection
Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized subjects who received at least one active study treatment (KSI-301 or aflibercept)
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| ID | Title | Description |
|---|---|---|
| BG000 | KSI-301 (Treatment Group A) | Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44. KSI-301: Intravitreal Injection |
| BG001 | Aflibercept (Treatment Group B) | Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Geographic Region | Count of Participants | Participants |
| ||||||||||||||||||
| BCVA in the Study Eye | Mean | Standard Deviation | Letters |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48. | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. | Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment. | Posted | Least Squares Mean | Standard Error | ETDRS Letters | Day 1 to Week 48 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. | Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment. | Posted | Mean | Standard Deviation | ETDRS Letters | Day 1 to Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Categorical improvements in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart | Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment. | Posted | Count of Participants | Participants | Day 1 to Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Categorical worsening in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart | Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment. | Posted | Count of Participants | Participants | Day 1 to Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. | Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment. | Posted | Count of Participants | Participants | Day 1 to Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. | Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment. | Posted | Count of Participants | Participants | Day 1 to Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) as assessed by a central reading center. | Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment. | Posted | Mean | Standard Deviation | Microns | Day 1 to Week 48 |
|
Adverse Events (AEs) reported through Week 52 or Early Termination (ET)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KSI-301 (Treatment Group A) | Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44. KSI-301: Intravitreal Injection | 4 | 276 | 39 | 276 | 110 | 276 |
| EG001 | Aflibercept (Treatment Group B) | Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. | 3 | 281 | 39 | 281 | 80 | 281 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Periorbital cellulitis - Study eye | Infections and infestations | Systematic Assessment |
| ||
| Viral infection | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
| ||
| Herpes zoster | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Respiratory syncytial virus infection | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Aortic valve incompetence | Cardiac disorders | Systematic Assessment |
| ||
| Aortic valve stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Atrioventricular block second degree | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure acute | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardio-respiratory arrest | Cardiac disorders | Systematic Assessment |
| ||
| Mitral valve incompetence | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Tricuspid valve incompetence | Cardiac disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Retinal detachment - Study eye | Eye disorders | Systematic Assessment |
| ||
| Eye pain - Study eye | Eye disorders | Systematic Assessment |
| ||
| Uveitis - Study eye | Eye disorders | Systematic Assessment |
| ||
| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Large intestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mesenteric vein thrombosis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis necrotising | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Paralysis | Nervous system disorders | Systematic Assessment |
| ||
| Paraparesis | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Dyskinesia | Nervous system disorders | Systematic Assessment |
| ||
| Generalised tonic-clonic seizure | Nervous system disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Sudden death | General disorders | Systematic Assessment |
| ||
| Infusion site extravasation | General disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Nephritis | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Extradural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pelvic fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Accidental overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Acetabulum fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cervical vertebral fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Facial bones fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Foreign body | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Stomal hernia | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Bile duct stone | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Peripheral arterial occlusive disease | Vascular disorders | Systematic Assessment |
| ||
| Aortic stenosis | Vascular disorders | Systematic Assessment |
| ||
| Arteriosclerosis | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypertensive crisis | Vascular disorders | Systematic Assessment |
| ||
| Blood loss anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Intraocular pressure increased - Study eye | Investigations | Systematic Assessment |
| ||
| Angioedema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Diabetic foot | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neovascular age-related macular degeneration - Fellow eye | Eye disorders | Systematic Assessment |
| ||
| Vitreous floaters - Study eye | Eye disorders | Systematic Assessment |
| ||
| Conjunctival haemorrhage - Study eye | Eye disorders | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Intraocular pressure increased - Study eye | Investigations | Systematic Assessment |
|
Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pablo Velazquez-Martin | Kodiak Sciences Inc | 1 (650) 281-0850 | ClinOps@kodiak.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2023 | Apr 4, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D014786 | Vision Disorders |
| D015354 | Vision, Low |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Rest of World |
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|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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